FDA Adverse Event
Malfunction
Summary report: N
OLM INTRACRANIAL PRESSURE MONITORING KIT
MDR report key: 3177317
·
Received June 12, 2013
Report
- Report Number
- 2023988-2013-00012
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Report Date
- June 12, 2013
- Manufacturer
- INTEGRA NEUROSCIENCES CA/USA
- Product Code
- GWM
- PMA / PMN Number
- K853864
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
CROSS REFERENCE WITH MFR # 2023988-2013-00010 (B)(4). THREE 1104B OLM INTRACRANIAL PRESSURE CATHETERS WITH DIFFERENT SERIAL NUMBERS WERE REPORTED FAULTY. THE CATHETERS HAD TO BE REVISED THREE TIMES IN THE SAME PATIENT. THIS REPORT INVOLVES THE THIRD CATHETER WHICH WOULD NOT FIT INTO THE FIRST BOLT AND HAD TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266204 | OLM INTRACRANIAL PRESSURE MONITORING KIT | NA | GWM | INTEGRA NEUROSCIENCES CA/USA | 305000267193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |